NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1563Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1563Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51662-1563-1516621563012 mL in 1 VIAL, MULTI-DOSE (51662-1563-1)Marketed from Jun 25, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Generic name (nonproprietary)
(sotradecol) sodium tetradecyl sulfate
Active ingredients
Tetradecyl hydrogen sulfate (Ester) — 30 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040541
Marketing start
Listing expires
Identifiers
Product ID 51662-1563_c59db022-bda9-1732-e053-2a95a90a24f8SPL ID c59db022-bda9-1732-e053-2a95a90a24f8SPL set ID c59db022-bda8-1732-e053-2a95a90a24f8RxCUI 204491UNII 6326W0DRHY

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N451662156301 followed by a unit qualifier and the quantity

Package 51662-1563-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS & USAGE Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1563

What is NDC 51662-1563?
51662-1563 is the product NDC for (Sotradecol) Sodium Tetradecyl Sulfate, Tetradecyl hydrogen sulfate (Ester) 30 mg/mL injection, solution, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
(Sotradecol) Sodium Tetradecyl Sulfate.
What is the active ingredient?
Tetradecyl hydrogen sulfate (Ester).
Who is the labeler?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for (Sotradecol) Sodium Tetradecyl Sulfate?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 040541

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040541
ProductStrengthForm · routeLabelerProduct NDC
Sodium Tetradecyl SulfateTetradecyl hydrogen sulfate (Ester) 10 mg/mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1562
Sotradecoltetradecyl hydrogen sulfate (ester)Tetradecyl hydrogen sulfate (Ester) 10 mg/mLInjection, SolutionIntravenousMylan Institutional LLC67457-162
Sotradecoltetradecyl hydrogen sulfate (ester)Tetradecyl hydrogen sulfate (Ester) 30 mg/mLInjection, SolutionIntravenousMylan Institutional LLC67457-163

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